Novartis’ cancer therapy Glivec (imatinib) can now be used in Europe to treat certain patients with gastrointestinal stromal tumours (GIST) up to three years after surgery.
The European Commission (EC) has approved an update to the labelling for the drug, which is the current standard of care for stomach cancer, authorising 36 months of adjuvant therapy for adults with KIT (CD117)-positive GIST whose estimated risk of GIST disease recurrence is more than 50 per cent.
Previously, Glivec had only been available in Europe to treat adults with GIST that could not be removed with surgery or had spread to other parts of the body, as well as adults who were at risk of GIST coming back after surgical removal.
The latest approval was based on a trial of 397 patients that compared a 36-month regimen to a 12-month regimen of Glivec to treat KIT+ GIST after surgery. Results of the study showed that at five years, 66 per cent of patients taking Glivec for three years after surgery were free of cancer recurrence compared to 48 per cent who had received Glivec for only one year after surgery.
Almost all patients in the trial experienced side effects while taking Glivec and 26 per cent of patients in the 36-month group discontinued their treatment for reasons other than GIST recurrence, compared to 13% in the 12-month group.Overall survival was also improved after five years in patients taking the extended treatment, with 92 per cent of patients using Glivec for three years after surgery alive compared to 82 per cent who had received Glivec for only one year after surgery.